Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT01655420
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2012-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Reported Outcomes With LASIK: PROWL-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D006956', 'term': 'Hyperopia'}, {'id': 'D001251', 'term': 'Astigmatism'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D015352', 'term': 'Dry Eye Syndromes'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020731', 'term': 'Keratomileusis, Laser In Situ'}], 'ancestors': [{'id': 'D048988', 'term': 'Corneal Surgery, Laser'}, {'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000074431', 'term': 'Keratectomy'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2012-07-30', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopia', 'Hyperopia', 'Astigmatism', 'Patient-reported outcomes', 'Patient satisfaction', 'Refractive Error', 'Emmetropia', 'Dry eyes', 'Glare', 'Halos', 'Patient expectations'], 'conditions': ['Laser in Situ Keratomileusis']}, 'referencesModule': {'references': [{'pmid': '27893066', 'type': 'RESULT', 'citation': 'Eydelman M, Hilmantel G, Tarver ME, Hofmeister EM, May J, Hammel K, Hays RD, Ferris F 3rd. Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies. JAMA Ophthalmol. 2017 Jan 1;135(1):13-22. doi: 10.1001/jamaophthalmol.2016.4587.'}, {'pmid': '27893063', 'type': 'RESULT', 'citation': 'Hays RD, Tarver ME, Spritzer KL, Reise S, Hilmantel G, Hofmeister EM, Hammel K, May J, Ferris F 3rd, Eydelman M. Assessment of the Psychometric Properties of a Questionnaire Assessing Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL). JAMA Ophthalmol. 2017 Jan 1;135(1):3-12. doi: 10.1001/jamaophthalmol.2016.4597.'}], 'seeAlsoLinks': [{'url': 'https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2587831', 'label': 'Full Manuscript Eydelman et al'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates a questionaire designed to measure satisfaction and ophthalmic-related quality of life (QoL) of 300 civilian participants prior to and three months following state-of-the-art laser in situ keratomileusis (LASIK).', 'detailedDescription': "The LASIK Quality of Life Collaboration Project (LQOLCP) is a government partnership among the FDA's Center for Devices and Radiological Health (CDRH), the Department of Defense, and the National Eye Institute (NEI). This project examines patient-reported outcomes (PROs) following LASIK surgery. This three-phased project is part of FDA's ongoing effort to better monitor and improve the safety and effectiveness of lasers used in LASIK surgery. PROWL-2 is the third phase of the larger LQOLCP project. The primary objective of PROWL-2 is to explore the psychometric properties of a computer-based questionnaire assessing the patient-reported outcomes of satisfaction and ophthalmic-related quality of life before and over a period of 3 months following LASIK. This questionnaire initially developed and examined in PROWL-1 (a military population) will be examined psychometrically in a civilian population. PROWL-2 is a prospective, multi-center, observational study in which a participant's pre-operative status will serve as the baseline for one-month and three-month post-surgical comparisons. Three hundred (300) participants planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism will be enrolled in this study from five (5) clinical sites across the United States. Additionally, routine clinical data will be collected pre- and post-operatively (e.g., best corrected visual acuity, manifest refraction, wavefront aberrometry, conreal topography, and other clinical assessments) and questionnaires will be independently administered pre-operatively and at the one-month and three-month post-operative visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals age of 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Investigators will be instructed to base subject eligibility on the Professional Use Information for their specific laser and keratome system, including but not limited to subjects who:\n* Are aged 21 years or older.\n* Have the ability to give informed consent.\n* Speak and read English fluently.\n* Have not previously had any form of refractive surgery, including prior LASIK or cataract surgery.\n* May benefit from increased spectacle independence.\n* Have been determined to be a good candidate for the LASIK procedure based on the investigator's assessment of medical and ophthalmic health, general cognitive function, and physical and social limitations.\n* Have a treatment target of bilateral emmetropia. Of note, an eye must be treated within 7 days of the fellow eye.\n* Express willingness and potential ability to return for all follow-up examinations through the 3-month follow-up exam under the care of the treating investigator.\n* Have access to a computer with internet service."}, 'identificationModule': {'nctId': 'NCT01655420', 'acronym': 'PROWL-2', 'briefTitle': 'Patient Reported Outcomes With LASIK: PROWL-2', 'organization': {'class': 'FED', 'fullName': 'Food and Drug Administration (FDA)'}, 'officialTitle': 'Patient-Reported Outcomes With LASIK: PROWL-2', 'orgStudyIdInfo': {'id': '20112124'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LASIK', 'description': 'Individuals aged 21 to 84 years planning to undergo refractive surgery using LASIK for myopia, hyperopia, or astigmatism', 'interventionNames': ['Procedure: LASIK']}], 'interventions': [{'name': 'LASIK', 'type': 'PROCEDURE', 'otherNames': ['Refractive surgery using LASIK for myopia, hyperopia, or astigmatism'], 'description': 'Laser eye surgery', 'armGroupLabels': ['LASIK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '46240', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': '20/20 Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Durrie Vision', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Food and Drug Administration (FDA)', 'class': 'FED'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}